Manager - Cmo

1 week ago

Mumbai Maharashtra, India Sun Pharmaceutical Industries Full time

Job Title Manager CMO Business Unit Global Quality Compliance Job Grade G10 -Manager-1 G9B SM-2 Location Mumbai At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world you ll find yourself becoming Better every day through continuous progress Exhibit self-drive as you Take charge and lead with confidence Additionally demonstrate a collaborative spirit knowing that we Thrive together and support each other s journeys Job Summary To ensure that SUN Pharma Quality and Compliance Standards and applicable global regulatory authorities requirements are met and that all CMOs achieve maintain and improve the adequate level of compliance through Quality Oversight for USA Markets Key responsibilities Participate in the initial evaluation of Contract Manufacturing Organizations CMOs Should possess sound knowledge of pharmaceutical manufacturing process Non-sterile Sterile formulations quality assurance regulations and auditing technique Should have experience in managing manufacturing operations at External contract manufacturing sites Lead oversee approve monitor Quality Management System QMS elements reported by CMOs including change control deviations incidents out of Specification OOS out of Trend OOT results and complaint investigations targeting for injectable OSD products manufactured for emerging markets Ensure that the CMO operations are in compliance with global regulatory standards FDA EMA WHO ICH and SUN internal quality systems Review and maintain quality agreements with CMOs to ensure compliance and quality standards Review the batch records validation protocols and analytical reports for sterile injectable formulation for USA Market Support for the project management team during the execution of exhibit scale-up batches at the CMO site Collaborate with cross-functional teams including Regulatory Affairs Manufacturing and Supply Chain to ensure product quality and compliance Drive continuous improvement initiatives and inspection readiness at CMOs Minimum 13 years of pharmaceutical QA experience with strong exposure to injectable manufacturing operations for Regulated markets Travel Estimate Job Requirements Educational Qualification M Sc B Pharm M Pharm Experience Tenure 14 years of Industry experience and working knowledge in regulatory environments Experience in handling quality managements systems or Production Experience Your Success Matters to Us At Sun Pharma your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth Join us at Sun Pharma where every day is an opportunity to grow collaborate and make a lasting impact Let s create a brighter future together Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees as assigned to this job Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent s

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